Oxygen facemask with capnography monitoring ports

ABSTRACT

An oxygen face mask to cover a user&#39;s nose and at least partially cover a user&#39;s mouth with lateral sampling ports; systems including such a face mask; and methods of using such a face mask.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present invention relates to oxygen delivering facemasks, systemsincluding such oxygen delivering facemasks, and methods of using suchfacemasks and systems.

BACKGROUND

A steady inflow of oxygen is required to sustain human life. A shortinterruption or reduction in a person's oxygen supply can rapidly leadto brain or body damage, or death. An individual with too little oxygenin his blood (hypoxemia) or at risk for developing hypoxemia may begiven oxygen. An individual able to breathe on his own may be givensupplemental oxygen therapy for various reasons and in various places.Oxygen may be given to an individual who has shortness of breath or COPD(chronic obstructive pulmonary disease). Supplemental oxygen may bedelivered to a patient who has suffered trauma or an acute myocardialinfarction (heart attack). Supplemental oxygen may be given duringcertain surgical interventions or during post-anesthesia recovery aftera surgical intervention. Supplemental oxygen may be given anywhere. Itmay be given, for example, in a person's home, in a clinic or in ahospital such as in a trauma center, an emergency room, an operatingroom, a recovery room, or an intensive care unit. A person who isreceiving supplemental oxygen therapy is generally weak, injured, orcompromised in some way. Such a person is prone to stop breathingbriefly or altogether. In order to determine if a person receivingsupplemental oxygen is continuing to breathe, an assay may be performed.A non-invasive, expiratory gas sampling device may be used to determineif the person is exhaling as evidence he is continuing to breathe.Commonly, the expiratory gas sampled is carbon dioxide.

Both facemasks and nasal cannula have been used to deliver supplementaloxygen and to sample carbon dioxide. U.S. Pat. No. 5,400,781 toDavenport discloses an oxygen mask with two openings in the floor of thechamber in front of the mouth that lead to an oxygen source and a carbondioxide monitor. U.S. Pat. No. 5,474,060 to Evans describes an oxygenmask with an inlet for directing a flow of gas (oxygen) to the interiorof the mask, and a port for allowing the exhaled air to flow through anda tube for directing the exhaled air to a monitoring apparatus. U.S.Pat. No. 6,247,470 to Ketchedjian uses a flexible lever arm near theface and connected to tubing to deliver oxygen and sample exhaled gases.U.S. Pat. No. 6,439,234 to Curti describes a nasal cannula with twoprongs, with the first prong for delivering oxygen and the second prongfor sampling carbon dioxide. WO 91/14469 teaches a nasal gas cannula andan oral gas capture member for delivering and capturing carbon dioxide.

Although these facemasks and cannulas attempt to solve some of theproblems with delivering oxygen to an individual and determining if heis breathing, none provides an easy to use, universal device that candeliver oxygen and sample an expiratory gas in a variety ofcircumstances. The present invention is directed to meeting these, aswell as other, needs.

SUMMARY OF THE DISCLOSURE

Described herein are devices, methods, systems, and kits useful foradministering and sampling gases from a mammalian body. The devices areparticularly useful for administering oxygen and sampling carbondioxide, though they may be used as a part of any appropriate treatmentprocedure.

One aspect of the invention provides a face mask to cover a user's noseand at least partially cover a user's mouth. In some embodiments, theface mask includes two or more lateral ports on opposing sides of amidline of the mask and is configured to deliver oxygen to a user. Insome embodiments, the face mask includes an oxygen inlet port having acenter, and at least one of the sampling ports is at least about 20 mmaway from the center of the oxygen inlet port. In some embodiments, theface mask includes a conduit coupled to a sampling port on only one sideof the mask.

In some embodiments, the face mask includes at least one vent configuredto release gas from the mask. In some embodiments the vent has a ventcenter and a center of the sampling port is within about 15 mm of thevent center. In some embodiments, the face mask includes a plurality ofvents and the plurality of vents is arranged around one of the samplingports.

In some embodiments, the face mask includes a mask reservoir portion forcontaining a pocket of gas and a lateral sampling port is in the maskreservoir portion. In some embodiments, the face mask is configured toremovably connect with a user's face to create a mask sealing portionconfigured to retain gas in the mask.

Another aspect of the invention provides a breathing mask systemincluding a face mask and a sensor and the facemask includes at leasttwo lateral sampling ports on opposing sides of a midline of the mask.The breathing mask may be configured to cover a user's nose and at leastpartially cover a user's mouth. The sensor may be coupled to a lateralport. In some embodiments, the sensor is configured to detect anexpiratory gas. In some embodiments, the system may include an alarmconfigured to provide a signal when a level of an expiratory gasdetected by the sensor is different from a threshold amount. In someembodiments, the sensor is configured to detect a carbon dioxidepressure (e.g., a carbon dioxide partial pressure). In some embodiments,the face mask may include an oxygen inlet port.

Another aspect of the invention provides a method of using an oxygenface mask having at least two lateral sampling ports on opposing sidesof a midline of the mask to sample an expiratory gas, the methodincluding the steps of choosing one lateral sampling port; and couplinga conduit with the port. In some embodiments, the method includes theadditional step of coupling an expiratory gas sensor to the conduit. Insome embodiments, the expiratory gas sensor is configured to assaycarbon dioxide and the method includes the step of assaying a partialpressure of carbon dioxide.

In some embodiments, the method includes the step of venting expiratorygas through a vent in the mask. In some embodiments, the method includesthe step of administering at least one of a nebulizer treatment and anaerosol treatment. In some embodiments, the method includes the step ofproviding at least about 60% oxygen. In some embodiments, the methodincludes expelling expiratory gas through a one-way valve.

Another aspect of the invention provides a kit including a face maskhaving at least two lateral sampling ports on opposing sides of amidline of the mask. The mask may be configured to provide oxygen. Insome embodiments, the kit may additionally include one or moreinstruction for use, a sampling conduit, a sensor, an oxygen conduit, arebreather reservoir, and a one way valve.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A is a front view of an oxygen facemask with lateral samplingports according to one aspect of the disclosure, and FIG. 1B is a frontview of an oxygen facemask with lateral sampling ports at the center ofthe respective vents.

FIG. 2 is a side view of a facemask with a lateral monitoring portaccording to one embodiment.

FIG. 3 is a side view of a facemask such as the one shown in FIGS. 1 and2 in use on a patient.

FIG. 4 shows a front view of a face mask with sampling conduit connectedto one of the lateral sampling ports.

FIG. 5A shows a short facemask to allow access to an individual's mouthand face.

FIG. 5B shows a bottom portion of a facemask removed from a full mask toform the short mask shown in FIG. 5A, according to one aspect of thedisclosure.

FIG. 6 shows a face mask kit according to one aspect of the disclosure.

DETAILED DESCRIPTION

The present invention includes a universal oxygen facemask fordelivering oxygen and sampling a respiratory gas for use in a variety ofclinical scenarios for an individual able to breathe on his own, butrequiring some supplemental oxygen. Respiratory gas (e.g., carbondioxide) may be monitored using the mask to ensure that the individualcontinues to breathe. Ensuring that the individual is breathing may beespecially important when an individual is under sedation or hasrecently experienced a status change such as a surgical procedure ortrauma. The mask may have two (or more) lateral sampling ports forsampling a respiratory gas. The ports may be located between a level ofthe nose and a level of the mouth when the mask is in use. FIGS. 1A and1B (front view) and FIG. 2 (side view) show mask 10 embodying featuresof the invention including left lateral sampling port 12 and rightlateral sampling port 14. Having two lateral sampling ports makes themask easier to use and allows for better samples to be taken. This maybe the case even though, in practice, a sample may be taken from onlyone of the ports. The second (or additional) lateral port may be unused.A mask with two lateral sampling ports allows the mask to be used innearly all clinical scenarios; mask manufacturing can be streamlined andthe best mask for almost any situation is readily available. A mask withat least two lateral sampling ports eliminates the need to have a seriesof different masks for different purposes. A mask having two lateralsampling ports may be the standard for use with all patients, and theuse of interchangeable components coupled with the mask for specificclinical scenarios may be the care path.

The facemask of the invention can be used for a variety of clinicalpurposes in a variety of settings. The facemask can be used while theperson needing oxygen is supine, lateral or prone; while the person'sface is covered with a drape; during nebulizer therapy; or during use ofa non-rebreather mask; during use of an oxygen calibration device (e.g.,a Venturi device); and/or during high flow oxygen therapy. In addition,the mask could be used for administering oxygen and monitoring anaspect(s) of respiratory physiology, such as end tidal CO₂ andrespiratory rate during a test of athletic endurance or cardiovascularhealth.

Ports high on the mask and lateral to the midline of the mask are moreaccessible compared with the location of ports on masks in the priorart. The lateral ports are easy to access in order to attach a samplingconduit (e.g., tubing) in a variety of patient positions andpatient-caregiver physical arrangements. If a monitoring port is low onthe mask, as with prior art masks, it is difficult to gain access to theport. First, accessing the port in the prior art masks is challengingdue to the port's immediate proximity to the oxygen port and the smallspace available to manipulate (e.g., attach and detach) a conduit. Thiscould be of particular importance in a small pediatric mask. Secondly, aport located near the oxygen inflow is out of view and cumbersome toreach in the most common operating room scenario, for which theanesthesia provider is positioned at the head of the patient's bed. Anydifficulty in accessing the monitoring port is magnified in challengingclinical situations such as an obese, prone, or laterally positionedpatient. Additionally, the patient's neck, chin or other body part mayget in the way of monitoring port access, especially in the case inwhich a patient is lying on his side.

The mask design of the disclosure also achieves the aims of separatingthe port from the other equipment and from other lines (e.g., the oxygeninput port, oxygen conduit, or oxygen bag). This separation prevents thesampling port from interfering with other equipment and lines as well aspreventing the other equipment and lines from interfering with samplingport access and sampling conduit access. This design also avoidsunnecessary stimulation of the patient by keeping lines and monitorsaway from the eyes and other sensitive parts of the face. FIGS. 1 and 2depict left, right lateral sampling ports 12, 14 positioned away fromthe oxygen inlet port center 21 of oxygen line inlet port 20 on mask 10,and out of the way of oxygen conduit coupler 8, shown coupling oxygeninlet port 20 with oxygen conduit 22. In one example, a center of thelateral sampling port is at least about 20 mm away from oxygen inletport center 21 of oxygen inlet port 20.

Having two sampling ports available allows a care provider (e.g., aphysician, nurse, or other person) to choose a convenient sampling port.For example, when a patient is lying supine while undergoing a surgicalprocedure, the care provider performing the respiratory gas monitoringoften sits at the patient's head. It is easier for the care provider toaccess one of the lateral ports and connect a tube or conduit to it formonitoring respiratory gas than it is to access a port that is obscuredby the patient's neck and may be underneath the oxygen inlet port/oxygenconduit. Depending on various factors, one specific lateral samplingport may be a better choice for the care provider to use. Ease ofattachment may be based on the positions of the care provider and/or themonitoring equipment to the patient. For example, a lateral side portcan be chosen and easily and directly accessed based on ergonomicconsiderations such as patient position, monitor position, and caregiverposition and handedness. The care provider does not need to reach acrossthe patient's face. As a patient may be conscious during a procedurewhen wearing an oxygen face mask, this is important. Having a hand closeto the eyes creates or worsens a feeling of confinement orclaustrophobia in a patient, which are common complaints from oxygenmask users.

Having at least two ports on the mask also means that if one of theports cannot be used, a second monitoring port is still available. Thismay be the case, for example, when an individual is lying on his side,such as when a surgical procedure is being performed on the other side,and one of the ports is blocked.

In another example, the mask may be used (e.g., to deliver oxygen)without using the sampling ports to obtain a sample. In another example,samples could be removed from two (or more) sampling ports.

The ports may be located laterally to the midline of the mask (e.g., onopposing sides of the midline). The ports may be between a level of thenose and a level of the mouth when the mask is in use. In one example,the ports are at or below the bottom of the nose (e.g., below about alevel of the nares). In another example, the sampling ports are abovethe level of the lower lip. In another example, the sampling ports areabove the level of the upper lip. The sampling ports may be positionedin any lateral position relative to the nose and mouth. The ports maycollect nasal gases, oral gases, or both. The ports may collect othergases (e.g., supplemental oxygen, room air). FIG. 3 shows a side view ofpatient 37 wearing mask 10 as described herein. Left lateral samplingport 12 is at a level between mouth 30 and nose 32.

The mask may have one or more exhalation vents (e.g., exhalation ports).FIGS. 1-3 show left, right exhalation vents 16, 18. An exhalationvent(s) may release or vent gas and other substance(s) from inside tooutside the mask. The gas may be an expiratory gas (e.g., carbon dioxideor oxygen). Although called an exhalation vent(s), the vent mayadditionally allow room air or other materials to move from outside themask to inside the mask in some embodiments. A vent(s) may move airwithin the mask and in particular may move air within a reservoir of themask. The mask may have a vent(s) on a midline of the mask, or on one orboth sides of the midline. There may be a plurality of exhalation vents.There may be one, two, or more exhalation vents. In one example theremay be 10 or more vents. A lateral sampling port may be located outsidean area encompassed by the exhalation vents, as shown in FIGS. 1-3. Alateral sampling port may be located near an exhalation vent. A lateralsampling port may be located as close to one or more exhalation vents aspossible, such as left sampling port 12 located near exhalation vents 16as shown in FIG. 3. In one example, a lateral sampling port may belocated about 1 mm away from an exhalation vent. In one example, thedistance between a center of a lateral sampling port and a vent is about15 mm. In another example, a distance between a center of a lateralsampling port and a center of the vents is about 15 mm.

A plurality of exhalation vents (e.g., perforations) may be arrangedaround a lateral sampling port. A plurality of vents 16 may define avent center 27, as shown on mask 10 in FIG. 1A. A port 14 may be locatedat or near a vent center 27, substantially surrounded by exhalationvents as shown in FIG. 1B. In another example, a sampling port isoutside an area of the vents and a distance between a center of asampling port and a center of the vents is about 15 mm.

The exhalation vents may have a point of attachment (e.g., a couplingpoint) 15 near or at the vent center as shown in FIGS. 2 and 3. Aflexible diaphragm may be coupled with a point of attachment to create aone way valve (e.g., over the vent(s)), such as for use with anon-rebreather apparatus. The one way valve may allow gas inside themask to move to outside the mask, while substantially not allowing gasoutside the mask (e.g., room air) to move inside the mask.

The exhalation vents may be low resistance to air flow as air flows outof the exhalation holes; locating the lateral sampling ports near theexhalation vents may allow more accurate sampling of exhaled gas as thegas is moved past the lateral sampling port. If gas is sampled near theinflow stream of oxygen, the sampling accuracy may be lowered. This mayespecially be the case in high minute ventilation scenarios when carbondioxide levels are low and/or oxygen flow rates are high.

Mask 10 may have reservoir 19 containing a pocket of gas (e.g., air) asshown in FIGS. 2 and 3. The reservoir may allow gas mixing and provide aspace near nose 32 (e.g., near the nostrils) and mouth 30 to facilitatebreathing. In one example, the reservoir may extend from a level nearthe mouth to a level near the nose when the mask is positioned on auser. In another example, the reservoir may extend to about the bottomof the nose when the mask is in use. In one example, the reservoirextends about 50 mm vertically, 50 mm horizontally, and 50 mm in theanterior posterior dimension. A sampling port may be located in thereservoir region of the mask. As shown in FIG. 3, left lateral port 12exits the mask from reservoir 19.

Positioning a sampling ports away from the oxygen inlet port may make iteasier (or even possible) for a care provider to change the oxygenconduit (e.g., tubing) leading to an oxygen inlet port or anotherconnector which might not be possible if a sampling port (or conduitconnected with a sampling port) is too close to the oxygen deliveryport. For example, it may be easier to change a nebulizer device coupledwith the oxygen inlet port without having a sampling port nearbyobstructing access. The sampling ports may be positioned far enough awayfrom an oxygen line connector to enable a care provider to attach both asampling conduit and a specialized apparatus to the mask including anebulizer, a nonrebreather, an oxygen calibration device (e.g., aVenturi device), or a high flow oxygen source.

A sampling port may have any shape or configuration that allows gas tomove through and to connect with a conduit or sampling device. The portmay be low profile or hardly visible. The sampling port may be e.g.,circular, square, hexagonal, or slotted. The sampling port may have amating part or fitting configured to removably connect with a differentmating part or fitting on a conduit, including a sensing conduit. Themating part may be any as known in the art (e.g., threads, slots, pins,lock-and-key mechanism, etc.). In one example, a mating part on thesampling port is a Luer-lock that can couple with a Luer-lock on asampling port conduit.

Any type of sampling conduit may be used. In one example, samplingconduit is a flexible polyurethane tubing. Sampling conduit may have anarrow diameter; the diameter may be smaller than a diameter of anoxygen conduit. In one example a sampling conduit may have about a ¼inch inner diameter or ⅜ inch outer diameter.

One method of using an oxygen face mask having two lateral samplingports according to the current disclosure includes choosing a lateralsampling port and coupling a conduit with the port. FIG. 4 shows mask 28with left, right lateral sampling ports 12, 14. Conduit 24 is connectedwith right lateral sampling port 14 to enable gas (e.g., carbon dioxide)sampling according to a method of the disclosure. The method may furtherinclude the step of obtaining a sample from the port. In one exampleobtaining the sample comprises obtaining a sample without an anestheticin it (e.g., without an inhaled anesthetic). The method may include thestep of coupling an expiratory gas sensor to the conduit; and theexpiratory gas sensor may be configured to detect carbon dioxide. Themethod may include the step of analyzing the sample for a component. Themethod may include the step of analyzing carbon dioxide (e.g., a partialpressure of carbon dioxide). The method may include the steps ofremoving the sampling conduit, and reattaching the conduit. The methodmay include the steps of providing oxygen, venting an expiratory gas,and/or administering a nebulizer or aerosol agent or treatment.

In one example, the method includes providing at least about 21-100%oxygen. The range includes providing room air (e.g., about 21% oxygen)to providing pure oxygen (e.g., around 100% oxygen), such as deliverableby a nonrebreather or high flow device. In one particular embodiment, atleast about 60% oxygen is provided. FIG. 4 depicts oxygen source 34providing oxygen through oxygen conduit 22 to oxygen inlet port 20. Theoxygen source can be any as known in the art (e.g., an oxygen tank or abag connected to an oxygen tank). In one example, monitoring may beperformed without providing supplemental oxygen (e.g., only providingroom air).

Any material may be sampled from the port. Any characteristic of thematerial may be analyzed. Gas may be sampled from the port or acomponent present with the gas may be sampled. The gas may contain othercomponents such a therapeutic nebulized or aerosolized component oragent. The gas may be expired gas. The expired gas may be mixed, inpart, with delivered oxygen, and/or room air before sampling. In oneexample, the gas may not contain expired air (e.g., if the patient isnot breathing). In one example, carbon dioxide is sampled (capnography).In another example, oxygen is sampled. In another example, end tidalpartial pressure of the gas (e.g., carbon dioxide) may be measured.

Any device or means (e.g., sensor) may be used to sample a gas. FIG. 4shows a sensor 38 coupled with sampling conduit 24 for analyzing asample from right sampling port 14. A sensor may be connected to asampling conduit, or the conduit may be the sensor. Any characteristicof a gas may be sensed. An amount of a gas, a change in a level of agas, and/or a change in a pressure of a gas may be sensed. A partialpressure of a gas may be assayed. In one example, carbon dioxide ismeasured and an infrared sensor is used (capnograph). In another case,carbon dioxide may be measured and a colorimetric sensor may be used(see e.g., U.S. Pat. No. 5,857,460 to Popitz).

A system according to the disclosure may include a facemask and one ormore components that can be used with the mask. The system may include acomponent configured to obtain, move, provide, sense, assay and/ormeasure a level of a gas. FIG. 4 shows a system 40 with a mask 28, asampling conduit 24, a sensor 38, an oxygen conduit 22, and oxygensource 34. The system may include a mask, a mask sealing agent, a facecontact agent (e.g., a lotion), sampling conduit, oxygen conduit, anoxygen reservoir (e.g., partial or full rebreather reservoir), a one wayvalve or valve cover and/or an oxygen source (e.g., tank). In oneparticular example, the system includes a face mask and a sensorconfigured to detect a characteristic of a gas, such as a carbon dioxidepartial pressure. The sensor may be coupled with or configured to becoupled with a lateral port.

The face mask may be packaged into a kit. A kit may have any componentconfigured to be used with the face mask. The kit may include e.g., aface mask, a sampling conduit, a sensor, an oxygen conduit, a rebreatherreservoir, a one way valve, and/or an instruction(s) for use. FIG. 6shows kit 60 with facemask 10, sampling conduit 24, and instruction foruse 62.

The facemask or facemask system or a component used with the facemaskmay include an alarm. The alarm may provide a signal in response to aresult from a component measurement. The alarm may be any (e.g., visual,auditory). The alarm may provide a signal when a level of an expiratorygas is at or different from a threshold amount (e.g., is above or belowa threshold amount). In one example, the alarm is auditory and providesa signal when a level of carbon dioxide is different from a thresholdlevel (e.g., when a partial pressure of carbon dioxide is below athreshold level).

Any material can be delivered through the mask to the patient that wouldbenefit the individual. Gas (e.g., room air, oxygen, and/or respiredair) may be delivered. Room air, oxygen, and/or respired air may bedelivered with or without also delivering an anesthetic agent and withor without a sample being monitored. Room air may be delivered throughvents in the mask, through an oxygen line connector, through anotherconnector, or along an unsealed or open edge of the mask. Room air maybe mixed with another gas (e.g., oxygen) and delivered.

In one example, oxygen is delivered through the oxygen inlet port. Theamount of oxygen delivered may be any therapeutic amount (e.g.,21-100%). The oxygen may be delivered at any flow (e.g., low, medium, orhigh flow).

The oxygen may be delivered at a relatively low flow rate. In anotherexample, respired air may be delivered with oxygen. A reservoir or bagconfigured to supply oxygen and respired air may be coupled with themask. The mask may have a one way valve on one or more exhalation ventsto release expired air to the room (e.g., a rebreather or partialrebreather mask) without substantially allowing room air into the mask.

The oxygen may be delivered to the face mask with little or no exhaledair delivered or remaining in the face mask (e.g., the mask or masksystem may be a non-rebreather or partial rebreather mask or masksystem). An exhalation vent may include a one-way valve configured toallow the release of gas (e.g., exhaled air) from the mask withoutallowing intake of room air. In one example, oxygen may be deliveredusing a reservoir bag. The reservoir bag may be connected with the maskusing an oxygen line connector or other connector and may be connectedwith a source of oxygen (e.g., an oxygen tank). The connection betweenthe reservoir bag and the mask may include a one way valve that preventsinhaled air from entering the reservoir. Any of the components may beconnected with the mask, or may be separate from the mask. A systemincluding the oxygen mask of the disclosure may include one of morecomponents for connecting with or using with the face mask.

The oxygen may be delivered at a relatively high flow or pressure (e.g.,4 to 10 L/min) into the mask (e.g., a Venturi mask). The high flow mayin turn cause a percentage of the oxygen in the mask to be higher orcontrolled (e.g., more constant).

Alternatively, a device for creating or delivering a nebulized agent(e.g., a nebulizer) or aerosoled agent may be connected with the oxygenline connector or another connector. Any material may be deliveredthrough a nebulizer device. For example, a bronchodilator orglucocorticoid may be delivered. In one example, albuterol is delivered.In another example, ipratropium may be delivered. This may be especiallybeneficial for a patient suffering from COPD or asthma.

The mask could instead have a single sampling port located along themidline of the oxygen mask. The sampling port may be located between thenose and the mouth. The sampling port may be located above and away froma mask component configured for delivering oxygen. A mask with a lowprofile sampling port at the midline may be easy to use and minimallyobstructive to the patient's view. In one example, the opening of thesampling port may point downwards (e.g., away from the user's eyes).

The mask may be any shape that fits over a portion of the patient's faceto provide oxygen and obtain a gas sample. The mask may be generallydiamond shaped or may be oval. The mask may have features to accommodatecontours of the face (e.g., the nose, chin, cheeks). Different masks mayhave features for different individuals (e.g., large patient, obesepatient, pediatric patient). The facemask may be configured to cover thenose and mouth. The mask may cover the nose and part of the mouth. Themask may cover the nose and all of the mouth. The mask may be configuredfor use on a mammal (e.g., a human). The facemask may exclude coveringthe eyes.

According to one embodiment, a mask with lateral sampling ports may be ashort mask, having a top portion without a bottom portion. A short maskallows access to the lower part of the patient's face (e.g., a patient'smouth). FIG. 5A shows short face mask 110 with various features,including right and left lateral sampling ports 12, 14, straps 26, andoxygen inlet port 20. Right lateral sampling port 14 is connected withthe sensor 38 through the conduit 24 for sampling an expiratory gas.Left lateral sampling port 12 is not being used in this example. A shortmask may be directly manufactured, or may be made by cutting a full(e.g., long mask) to remove a bottom portion of the face mask. FIG. 5Bshows a bottom portion 111 of a face mask that has been removed from atop portion, to create a face mask such as face mask 110 of FIG. 5A.

In another embodiment, a mask may not have exhalation ports. Forexample, a mask open at the bottom, such as a short mask shown in FIG.5, might not need exhalation ports. Prior art masks having a samplingport closer to the bottom of the mask are cumbersome to use inprocedures in which the bottom part of the mask may be removed but whereexpiratory gases still need to be measured. Access to the lower part ofthe patient's face may be for any reason. A short mask may allow anendotracheal tube, endoscope, or echocardiogram probe to be insertedinto the patient's mouth. The endotracheal tube may provide oxygen andanesthesia to the patient. In one example, access to the patient's mouthmay allow nourishment or fluids to be provided. In another example,access may allow a procedure to be formed, such as a facial procedure orsurgery or dental work.

The mask may be any size to fit an individual. In one example, the maskmay be configured to fit onto most average adults. The mask may beconfigured to fit an especially large or obese individual (e.g., may belarger or may have a different shape). In another example, the mask maybe configured to fit a child. In another example, the mask may beconfigured to fit a baby.

The mask may have a sealing portion to removably seal or connect withthe user's face. The sealing portion may retain gas in the mask; thesealing portion may reduce or prevent expiratory gas and/or oxygen fromescaping from the mask. The sealing portion may be an edge portion ofthe mask. The mask may have special features (e.g., silicone edges, asealing air pocket, lubricant, etc.) to improve the connection orremoval of the mask relative to the face or to make the mask morecomfortable when in use.

The mask may have any type of fastener or holder to hold the mask inplace (e.g., an elastic loop to go behind the head, loops to go aroundthe ears, etc.).

As for additional details pertinent to the present invention, materialsand manufacturing techniques may be employed as within the level ofthose with skill in the relevant art. The same may hold true withrespect to method-based aspects of the invention in terms of additionalacts commonly or logically employed. Also, it is contemplated that anyoptional feature of the inventive variations described may be set forthand claimed independently, or in combination with any one or more of thefeatures described herein. Likewise, reference to a singular itemincludes the possibility that there are plural of the same itemspresent. More specifically, as used herein and in the appended claims,the singular forms “a,” “and,” “said,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is furthernoted that the claims may be drafted to exclude any optional element. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely,” “only” and the like inconnection with the recitation of claim elements, or use of a “negative”limitation. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe subject specification, but rather only by the plain meaning of theclaim terms employed.

1. A face mask to cover a user's nose and at least partially cover auser's mouth and configured to deliver oxygen to a user, the face maskcomprising: a reservoir adapted to contain a pocket of gas; an inletport configured to deliver gas to the reservoir; first and second ventson opposite sides of a midline of the mask, each vent including multiplevent ports configured to vent gas from the reservoir through the maskinto the atmosphere; and first and second sampling ports extendingthrough the mask to be in fluid communication with the reservoir, eachof the first and second sampling ports located on or within a circlecircumscribed around the respective vent ports and capable of beingcoupled to a conduit used to sample and analyze gas from the reservoir.2. The face mask of claim 1 further comprising a conduit configured tobe coupled to the first sampling port wherein the second sampling portis not coupled to the conduit during normal face mask use.
 3. The facemask of claim 1 further comprising an oxygen inlet port.
 4. The facemask of claim 3 wherein a center of each of the first and secondsampling ports is at least about 20 mm away from a center of the oxygeninlet port.
 5. A breathing mask system comprising a face mask configuredto cover a user's nose and at least partially cover a user's mouth, theface mask comprising: a reservoir adapted to contain a pocket of gas;first and second lateral sampling ports on opposing sides of a midlineof the mask, the first and second lateral sampling ports capable ofbeing coupled to a conduit used to sample gas from the reservoir; firstand second vents configured to release gas from the reservoir throughthe mask to the atmosphere, the first lateral sampling port locatedadjacent the first vent at a distance that enables the sampling of gasthat will pass from the reservoir through the first vent, the secondlateral sampling port located adjacent the second vent at a distancethat enables the sampling of gas that will pass from the reservoirthrough the second vent.
 6. The system of claim 5 further comprising analarm configured to provide a signal when a level of an expiratory gasdetected by a sensor is different from a threshold amount.
 7. The systemof claim 5 wherein a sensor is coupled to the first lateral samplingport, the sensor configured to detect an expiratory gas.
 8. The facemask of claim 1 wherein the first and second vents are structured toallow gas to pass only one way through the vents.
 9. The system of claim6 wherein the first and second sampling ports are at a distance of 1 mmto 15 mm from the respective first and second vents.
 10. The system ofclaim 6 comprising a sensor coupled to the first lateral sampling port,the sensor capable of detecting an expiratory gas.
 11. The system ofclaim 6, wherein the face mask further comprises an oxygen inlet port.12. The system of claim 11 wherein a center of each of the first andsecond sampling ports is at least about 20 mm away from a center of theoxygen inlet port.
 13. The system of claim 6 wherein the first andsecond vents are structured to allow gas to pass only one way throughthe vents.
 14. A medical face mask to cover a user's nose and at leastpartially cover a user's mouth and configured to deliver oxygen to auser, the face mask comprising: a reservoir adapted to contain a pocketof gas; an inlet port configured to deliver gas to the reservoir; firstand second vents on opposite sides of a midline of the mask and capableof venting gas from the reservoir through the mask into the atmosphere;first and second lateral sampling ports extending through the mask to bein fluid communication with the reservoir, each of the first and secondsampling ports located close enough to the vents to enable sampling ofexhaled gas as the exhaled gas is moved from the reservoir past thefirst or second lateral sampling port to the respective first or secondvent.
 15. The medical face mask of claim 14 wherein the inlet portcomprises an oxygen inlet port.
 16. The medical face mask of claim 15,wherein a center of each of the first and second sampling ports is atleast about 20 mm away from a center of the oxygen inlet port.
 17. Themedical face mask of claim 14 wherein the first and second vents arestructured to allow gas to pass only one way through the vents.
 18. Themedical face mask of claim 14 the first and second sampling ports arelocated within the respective first and second vents.
 19. The medicalface mask of claim 18 wherein the first and second sampling ports arelocated at a center of the respective first and second vents.
 20. Themedical face mask of claim 18 wherein the first and second samplingports are located off-center of the respective first and second vents.21. The medical face mask of claim 14 wherein the first and secondsampling ports are at a distance of 1 mm to 15 mm from the respectivefirst and second vents.